BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS— 510(k) K905707

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K905707 for BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS, Substantially Equivalent on 1991-02-13. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 1990-12-21
Decision date: 1991-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

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Adverse events under product code FGE

product code FGE

Death: 52
Injury: 2,347
Malfunction: 9,798
Other: 1
Total: 12,198

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.